Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction

NCT02686021 | Completed Phase 4

• 1 other identifier: EKNZ 2015-284
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• area under the curve for pain in the first 12 postoperative hours

  The primary outcome is the area under the curve for pain in the first 12 postoperative hours, as assessed by the numeric rating scale

  first 12 postoperative hours

Secondary Outcomes (5)

• area under the curve for pain in the first 18 postoperative hours

  first 18 postoperative hours

• highest pain score

  total observation period (maximum 18 hours)

• night time pain

  first night after the intervention

• need for and timing of rescue medication

  total observation period (maximum 18 hours)

• haemorrhage requiring intervention

  total observation period (maximum 18 hours)

Study Arms (3)

Metamizole and Ibuprofen

EXPERIMENTAL

all patients (n=42) will receive metamizol and ibuprofen in one session. In the other session half will receive metamizol and placebo (n=21) and the other half will receive ibuprofen and placebo. The order will be randomized (balanced).

Drug: Metamizole and Ibuprofen

Metamizole and Placebo

ACTIVE COMPARATOR

This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21

Drug: Metamizole and Placebo

Ibuprofen and Placebo

ACTIVE COMPARATOR

This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21

Drug: Ibuprofen and Placebo

Interventions

Metamizole and Ibuprofen DRUG

Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Metamizole and Ibuprofen

Metamizole and Placebo DRUG

Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Metamizole and Placebo

Ibuprofen and Placebo DRUG

Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Ibuprofen and Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia)
• able to understand the study and the NRS scale

You may not qualify if:

• simultaneous both sided extraction or only upper third molar extraction
• general anesthesia
• known or presumed abnormal coagulation status
• known or presumed liver or renal dysfunction
• contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against NSAIDS, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding)
• contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against Nonsteroidal anti-inflammatory drugs (NSAID), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding)
• pregnancy and breast feeding mothers

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anesthesia, University of Basel Hospital

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dipyrone; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Wilhelm Ruppen, PD Dr. med

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 19, 2016
• Study Start: February 15, 2016
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

CH (1)